The FIBRINOGEN study; to evaluate and compare the ex vivo effects of recombinant human fibrinogen (rhFGN) , variants rhFbgAa610 and Aa847, and Haemocomplettan supplementation on blood coagulatio

Recruiting

• Conditions: coagulation disturbance; coagulopathy; 10064477; 10011082

• Registration Number: NL-OMON34478
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

- Coronary artery bypass graft (CABG), isolated and on-pump
- Preoperative fibrinogen level <3,8g/L
- Left ventricle ejection fraction > 35%
- Age >18 years

Exclusion Criteria

- Any other procedure than on-pump CABG
- Preoperative fibrinogen level >3,8g/L
- Emergency surgery
- History of bleeding diathesis or coagulopathy
- Participation in any study involving an investigational drug or device
- Inability to understand the study information and/or sign informed consent
- Usage of FFPs or fibrinogen before or during the CABG procedure

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Several parameters will be studied in the collected blood samples, e.g.:<br /><br><br /><br>- ROTEM analysis<br /><br>- clotting time<br /><br>- clot formation time<br /><br>- maximum clot firmness<br /><br>- clot firmness after 10 minutes<br /><br>- clot firmness after 20 minutes<br /><br>- lysis onset time<br /><br>- lysis time<br /><br><br /><br>- Coagulation and fibrinolysis activation assays</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>NVT</p><br>